西格列汀临床使用.ppt

西格列汀的临床应用 西格列汀治疗中国、印度和韩国2型糖尿病患者的有效性和安全性 研究目的 在中国、印度和韩国，对饮食和运动血糖控制不充分的2型糖尿病患者，使用西格列汀18周 评估18周的西格列汀100 mg/天的有效性和安全性 研究设计 患者分布 基线特征 HbA1c较基线的改变 (FAS 人群) 与安慰剂相比，LSM HbA1c较基线改变，按基线HbA1c分层， (FAS人群) FPG较基线的改变 (FAS人群) 2小时PPG较基线的改变 (FAS人群) HOMA-β较基线的改变 (FAS人群) 分泌指数较基线的改变(FAS人群) 总结和结论 相比安慰剂，18周的西格列汀治疗可获得 较低的HbA1c，FPG和2小时PPG水平 b细胞功能改善 HbA1c的改变 FPG的改变 2型糖尿病患者 非劣效比较 西格列汀联合胰岛素治疗 HbA1C达标率 空腹血糖及2-小时餐后血糖自基线改变 24周时，接受初始联合治疗的高基线水平患者血糖/A1c迅速改善 研究设计 基线特征 24周显著改善HbA1c HbA1c-Lowering Efficacy of Sitagliptin at Week 30 Was Noninferior to That of Glimepiride in Patients Inadequately Controlled on Metformin This slide shows HbA1c values over time by treatment group using the per-protocol population. Sitagliptin was noninferior to glimepiride in reducing HbA1c at week 30 (ie, the upper limit of the 95% confidence interval for the least squares mean between-group difference was 0.16%, less than the prespecified noninferiority margin of 0.40%).1 PurposeTo present data showing change from baseline in HbA1c over time in patients treated with the addition of sitagliptin or glimepiride. Takeaway HbA1c-lowering efficacy of sitagliptin at Week 30 was noninferior to that of glimepiride in patients inadequately controlled on metformin alone. Arechavaleta 2010 p.164, Table 2p.164, Fig. 2 Arechavaleta 2010 p.162, D Arechavaleta 2010 p.162, Cp.164, Table 2 1. Arechavaleta R et al. Diabetes Obes Metab. 2011;13(2):160–168. * The efficacy and safety of sitagliptin has been assessed in 5 multinational, randomized, placebo-controlled, double-blind, phase III studies and one additional phase II study in Japan for the treatment of patients with type 2 diabetes and poor glycemic control. Three monotherapy, placebo-controlled studies 18 weeks1 24 weeks2 12 weeks3 (phase II) Three add-on therapy studies Metformin 24 weeks4 52-week active control5 Pioglitazone 24 weeks6 (peroxisome proliferator activated receptor [PPAR?] agonist)7 References 1. Raz I, Hanefeld M, Xu L, et al, for the Sitaglipti